NEWS/PR

AIDOT Receives Korea’s First MFDS Approval for Ultra-Lightweight On-De…
AIDOT 2026-01-06

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AIDOT announced that its AI-based cervical cancer diagnostic solution, Cerviray AI, has received official approval from the Korean Ministry of Food and Drug Safety (MFDS) for the country’s first ultra-lightweight on-device AI diagnostic functionality. This approval allows AI computations to be performed directly on the device itself, in addition to the traditional server-based system.

The key feature of the on-device AI is that it does not require an internet connection. Captured cervical images can be immediately analyzed and diagnosed by AI, making it highly practical in:

  • Rural and remote areas with limited medical infrastructure

  • Emergency situations

  • Environments with strict internet security regulations

By providing instant results without network latency or data uploads, the on-device AI is expected to significantly enhance clinicians’ diagnostic efficiency.

An AIDOT representative explained,
“This MFDS approval confirms that Cerviray AI is Korea’s only cervical cancer AI solution capable of both server-based and on-device operations. It lays the foundation for improving women’s health in areas with limited healthcare access and where data privacy is critical.”

Cerviray AI has been consistently used in domestic and international healthcare institutions and public health projects, drawing growing interest from multiple national health ministries and international organizations. With the new on-device approval, its global competitiveness is expected to increase further.

The solution uniquely identifies four types of cervical lesions, including CIN1, and accurately marks lesion locations based on AI analysis, making it the only system in Korea with this capability.

Looking ahead, AIDOT plans to expand its on-device AI technology beyond women’s health to a broader range of digital healthcare applications.


Korea Economic TV / November 17, 2025 / Senior Reporter Jaejun Yang

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